FDA expands approval of closed-looped insulin delivery system

(HealthDay)—Approval of the MiniMed 670G hybrid closed looped system for diabetes management has been expanded to include individuals aged 7 to 13 years with type 1 diabetes, according to a report published by the U.S. Food and Drug Administration (FDA).

The MiniMed 670G hybrid closed looped system was originally approved in September 2017 for use in patients age 14 years and older with type 1 diabetes. The device works by measuring glucose levels in the body every five minutes and automatically adjusting insulin delivery. The system includes a sensor that measures glucose levels under the skin, an insulin pump, and an infusion patch connected to the pump. Users need to manually request insulin doses to counter carbohydrate consumption.

The FDA evaluated data from a clinical trial of the system in 105 individuals aged 7 to 11 years. Participants wore the device for about 3.5 months, and three phases of the study assessed home and remote use. No serious adverse events were recorded in association with use of the device, which was considered safe for people aged 7 to 13 years with type 1 diabetes.

"Today we're extending these opportunities to younger children who are especially vulnerable to the impact of this disease, such as the disruptions in sleep that can be caused by the need for frequent blood glucose checks," FDA Commissioner Scott Gottlieb, M.D., said in a statement.

This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no
part may be reproduced without the written permission. The content is provided for information purposes only.

E-mail the story

FDA expands approval of closed-looped insulin delivery system

Note

Your email address is used only to let the recipient know who sent the email. Neither your address nor the recipient's address will be used for any other purpose.
The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form.

Your message

Newsletter sign up

Get weekly and/or daily updates delivered to your inbox.
You can unsubscribe at any time and we'll never share your details to third parties.

Your Privacy

This site uses cookies to assist with navigation, analyse your use of our services, and provide content from third parties.
By using our site, you acknowledge that you have read and understand our Privacy Policy
and Terms of Use.